(86 days)
The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.
The STS range of sleeves, are three chamber graduated, sequential compression sleeves, to be used in conjunction with the Huntleigh AC600 Flowtron Universal pump (K010744). The STS range of compression sleeves consist of two sheets of PVC laminate materials welded together to form three chambers. The size and shape of these chambers are similar to the predicate device, as is the method of fitting to the patient's limb. On the proposed device, a single tube into the lower chamber inflates the complete sleeve. proposed devices and gradient inflation of the middle and upper chambers is achieved by a series of bleed channels between chambers and bleed orifices to atmosphere. On the predicate device, the material in contact with the patient's skin is non-woven fibre. The STS has a layer of polyester foam against the patient's skin, identical in composition to other approved Huntleigh sleeves. The systems have similar fault alarms, i.e. low pressure, blocked/kinked tubes, and system faults.
The provided text describes a 510(k) premarket notification for STS Compression Sleeves, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as would be found for an AI/ML-based device.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and training sets is not applicable in this context. The document describes a non-clinical equivalence testing rather than a clinical study or a study validating an AI/ML algorithm.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly defined with quantitative acceptance criteria and performance statistics as would be for an AI/ML device.
The determination of substantial equivalence for this device is based on non-clinical, inflation performance testing. The acceptance criterion implicitly is that the Huntleigh STS compression sleeves demonstrate similar inflation performance (pressure/time cycle) to the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Similar pressure/time cycle results to predicate device (Kendall SCD Therapeutic System K890938) | - Inflation sequence is similar.- Pressures in each chamber are similar.- Compresses a similar area of the patient's limb.- Made from similar materials. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified quantitatively. The text states "The sleeves are tested by fitting to a subject's limbs," implying at least one subject, but no specific number is given.
- Data Provenance: The testing appears to be internal to Huntleigh Healthcare, Inc. The country of origin of the data is not specified, but the company is based in the USA (New Jersey). The testing is prospective for the purpose of this 510(k) submission, as it was performed to support the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. There is no "ground truth" in the sense of expert medical diagnosis or labeling for this type of device. The assessment is based on physical performance comparisons to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication process is described for this non-clinical performance test. The comparison is objective (inflation metrics) against a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an AI/ML device, nor a diagnostic device that would typically involve human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (compression sleeves), not an algorithm or AI/ML product.
7. The Type of Ground Truth Used
Predicate Device Performance Data. The "ground truth" (or more accurately, the comparator) for determining equivalence is the established performance characteristics (inflation pressure/time cycles) of the legally marketed predicate device, the Kendall SCD Therapeutic System (K890938).
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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SEP 2 1 2001
Image /page/0/Picture/2 description: The image shows the logo for Huntleigh Healthcare. The logo consists of the word "Huntleigh" in a serif font, with the word "HEALTHCARE" in a smaller serif font directly below it. Above the text is a symbol that resembles a stylized building or structure, composed of several horizontal bars with a vertical gap in the center.
510(k) SUMMARY
STS Compression Sleeves
| Company | Huntleigh Healthcare Inc40 Christopher WayEatontownNew Jersey |
|---|---|
| Contact | Audrey WitkoPhone 732 578 9898Fax 732 460 5809 |
| Summary Preparation Date | 19 June 2001 |
| Trade Name | STS20 Knee Length SizeSTS30 Thigh Length Medium SizeSTS40 Thigh Length Large Size |
| Common Name | Gradient, Sequential Compression Sleeves |
| Classification Name | Sleeve, Limb, Compression (JOW) |
| Predicate Device | Kendall SCD Therapeutic System K890938 |
Device Description
The STS range of sleeves, are three chamber graduated, sequential compression sleeves, to be used in conjunction with the Huntleigh AC600 Flowtron Universal pump (K010744)
Intended Use
The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.
Summary of Technological Characteristics
The STS range of compression sleeves consist of two sheets of PVC laminate materials welded together to form three chambers. The size and shape of these chambers are similar to the predicate device, as is the method of fitting to the patient's limb.
On the predicate device, separate tubes individually inflate the three chambers. On the proposed device, a single tube into the lower chamber inflates the complete sleeve. proposed devices and gradient inflation of the middle and upper chambers is achieved by a series of bleed channels between chambers and bleed orifices to atmosphere.
On the predicate device, the material in contact with the patient's skin is non-woven fibre. The STS has a layer of polyester foam against the patient's skin, identical in composition to other approved Huntleigh sleeves.
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The systems have similar fault alarms, i.e. low pressure, blocked/kinked tubes, and system faults.
Determination of Substantial Equivalence
The determination of Substantial Equivalence is based on non-clinical, inflation performance testing. The sleeves are tested by fitting to a subject's limbs and the pressure/time cycle results compared.
Equivalence Testing Results
The sleeves are made from similar materials and compress a similar area of the patient's limb. The inflation sequence and pressures in each chamber are similar.
Therefore, we propose that the clinical treatment that the patient receives will be equivalent.
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right.
SEP 2 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Audrey Witko Huntleigh Healthcare, Inc. 40 Christopher Way Eatontown, NJ 07724
Re: K012008
Trade Name: STS Range Models STS20, STS30, and STS40 Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compression Regulatory Class: Class II (two) Product Code: JOW Dated: June 27, 2001 Received: June 27, 2001
Dear Ms. Witko:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Audrey Witko
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
signature
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
STS Compression Sleeves
| Ver/3 - 4/24/96 | |
|---|---|
| Applicant: | Huntleigh Healthcare Inc. |
| 510(k) Number (if known): | Not known at present K012008 |
| Device Name: | STS |
| Indications For Use: | |
| The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow. |
Division of Cardiovascular & Respiratory Devices
510(k) Number K012006
(PLEASE DO NOT WRITE BELOW THIS LIME – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).